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Drugs and Medicinal Substances

Activase

Blood and Blood Forming Organ Agents

Alteplase, sold under the brand name Activase in the United States and Actilyse elsewhere, is a biosynthetic form of human tissue-type plasminogen activator, commonly abbreviated t-PA. It is a thrombolytic, or clot-dissolving, medication given intravenously or intraarterially to treat acute ischemic stroke, acute ST-elevation myocardial infarction, pulmonary embolism accompanied by low blood pressure, and blocked central venous catheters. It works by binding to fibrin within a blood clot and activating clot-bound plasminogen, converting it into the enzyme plasmin, which then cleaves the cross-links between polymerized fibrin molecules so the clot breaks down. Alteplase received its first United States regulatory approval in November 1987 for treatment of myocardial infarction, and its use was later extended to ischemic stroke and pulmonary embolism. It is included on the World Health Organization's Model List of Essential Medicines, added in 2019, reflecting its role as a standard emergency treatment for clot-related vascular events where restoring blood flow quickly can limit permanent tissue damage.

Facts
Classification
Approval Status
Approved 1
ATC ClassSourced to the subject's own account
B: Blood and Blood Forming Organs 2
Route of Administration
Intravenous 3
WHO Essential MedicineSourced to the subject's own account
Complementary List 4
First Approved / Isolated Year
1987 5
Sources
1. Alteplase (Wikipedia)
  • https://en.wikipedia.org/wiki/Alteplase, lead section
    ed central venous catheter. Alteplase is given by injection into a vein or artery. Alteplase is the same as the normal human plasminogen activator produced in vascular endothelial cells and is synthesized via recombinant DNA technology in Chinese hamster ovary
  • Lead section, approval-status statement
    It is on the World Health Organization's List of Essential Medicines.
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code B
Quote, First-level anatomical group codes, Code B
Blood and blood forming organs
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3. Wikipedia
Wikipedia contributors, Wikimedia Foundation
4. WHO Model List of Essential Medicines (Wikipedia)
WikipediaWHO EML 23rd List (2023), section 12.5.2 thrombolytic medicines, Complementary List (Activase is the brand of alteplase)
Quote, WHO EML 23rd List (2023), section 12.5.2 thrombolytic medicines, Complementary List (Activase is the brand of alteplase)
alteplase Powder for injection: 10 mg; 20 mg; 50 mg in vial
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5. DailyMed: Activase (alteplase) Label
Highlights of Prescribing Information
Quote, Highlights of Prescribing Information
Activase (alteplase) for injection, for intravenous use Initial U.S. Approval: 1987 RECENT MAJOR CHANGES Dosage and Administration ( 2.5 ) 09/2022 INDICATIONS AND USAGE Activase is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS).
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